tDCS + CCFES for Stroke-related Hand Weakness

Overseen By David Cunningham, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MetroHealth Medical Center

Must not be taking: Seizure medications

Disqualifiers: Neurological conditions, Seizure disorder, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

63 Participants Needed

Trial Summary

What is the purpose of this trial?

After a stroke, it is very common to lose the ability to open the affected hand. Occupational and physical rehabilitation therapy (OT and PT) combined with non-invasive brain stimulation may help a person recover hand movement. The purpose of this study is to compare 3 non-invasive brain stimulation protocols combined with therapy to see if they result in different amounts of recovery of hand movement after a stroke.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are on medications that lower the seizure threshold, you may not be eligible to participate.

What data supports the effectiveness of this treatment for stroke-related hand weakness?

Research shows that transcranial direct current stimulation (tDCS) can improve arm and hand function in stroke patients when combined with physical and occupational therapy. Studies have found that different tDCS setups can lead to significant improvements in upper limb function, suggesting that tDCS may enhance rehabilitation outcomes for stroke-related hand weakness. ^{1 2 3 4 5}

Is tDCS + CCFES safe for humans?

Transcranial Direct Current Stimulation (tDCS) is generally considered safe for humans when used at an intensity of 4 mA or less for up to 60 minutes per day, with no severe complications reported in studies. However, it can cause mild skin irritation, and caution is advised, especially for vulnerable groups like children and the elderly. ^{6 7 8 9 10}

What makes the tDCS + CCFES treatment for stroke-related hand weakness unique?

This treatment is unique because it combines transcranial direct current stimulation (tDCS), which uses a mild electrical current to stimulate the brain, with contralaterally controlled functional electrical stimulation (CCFES), which helps improve hand function by stimulating the muscles directly. This dual approach aims to enhance motor recovery more effectively than traditional therapies alone. ^{1 2 11 12 13}

Research Team

David A Cunningham, PhD

Principal Investigator

MetroHealth Medical Center and Case Western Reserve University

Eligibility Criteria

This trial is for adults aged 21-90 who've had a stroke within the last 6-24 months, resulting in upper limb weakness but can still open their hand somewhat. They must be able to follow commands, remember things short-term, and sit unassisted. Excluded are those with seizure disorders, other neurological conditions, implanted electronic devices, pregnancy, recent Botox injections in the arm muscles or severe cognitive impairments.

Inclusion Criteria

I can move my shoulder and elbow enough to use my hand for table tasks.

I have weakness in one arm, making it hard to fully extend my fingers.

You have a specific score on a test that measures hand movement ability.

Exclusion Criteria

I cannot feel my arm, forearm, or hand.

I cannot move my hand or shoulder without severe pain.

I have severe difficulties in thinking and communicating.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three tDCS protocols combined with CCFES-mediated occupational therapy for 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

Treatment Details

Interventions

• Active conventional tDCS montage plus CCFES
• Active unconventional tDCS montage plus CCFES
• CCFES with Occupational Therapy
• Sham tDCS plus CCFES

Trial Overview The study tests three types of non-invasive brain stimulation combined with occupational therapy to improve hand movement after a stroke. Participants will receive either conventional tDCS (transcranial direct current stimulation), unconventional tDCS montages plus CCFES (Contralaterally Controlled Functional Electrical Stimulation), or sham tDCS plus CCFES.

Participant Groups

Group I: Active conventional tDCS plus CCFES Active Control 2 Interventions

The conventional tDCS montages involves placing the surface anode electrode on the scalp of the lesioned hemisphere and the surface cathode electrode on the scalp of the non-lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group II: Active unconventional tDCS plus CCFES Active Control 2 Interventions

The unconventional tDCS montages involves placing the surface anode electrode on the scalp of the non-lesioned hemisphere and the surface cathode electrode on the scalp of the lesioned hemisphere. TDCS will deliver a low current while participants are undergoing CCFES-mediated functional task practice.

Group III: Sham tDCS plus CCFES Placebo Group 2 Interventions

The sham tDCS montages involves placing the surface electrodes on the scalp over the lesioned and the non-lesioned hemisphere. TDCS will not be delivered during CCFES-mediated functional task practice.

Active conventional tDCS montage plus CCFES is already approved in United States, European Union for the following indications:

Approved in United States as Transcranial Direct Current Stimulation for:

• Post-stroke upper extremity hemiplegia
• Motor function rehabilitation

Approved in European Union as Transcranial Direct Current Stimulation for:

• Post-stroke motor function rehabilitation
• Neurological rehabilitation

Who Is Running the Clinical Trial?

MetroHealth Medical Center

Lead Sponsor

Trials

125

Recruited

22,600+

Findings from Research

In a study of 32 stroke inpatients, those who received bihemispheric transcranial direct current stimulation (tDCS) alongside physical and occupational therapy showed significantly greater improvements in upper extremity motor function compared to those who received sham tDCS.

The most notable benefits were observed in chronic stroke patients (over 6 months post-stroke), indicating that tDCS may be particularly effective for this group in enhancing their functional independence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. Alisar, DC., Ozen, S., Sozay, S.[2020]

Cathodal transcranial direct current stimulation (c-tDCS) applied to the unaffected primary motor cortex, combined with conventional occupational therapy, led to a significant 10-point improvement in arm-hand function for patients recovering from acute ischemic stroke, compared to only a 2-point improvement in the control group.

This study involved 16 patients with severe arm-hand weakness and suggests that c-tDCS may enhance rehabilitation outcomes, indicating the need for larger studies to confirm these findings and explore long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial. Rabadi, MH., Aston, CE.[2022]

In a clinical trial with 10 stroke patients, different tDCS electrode montages showed that bilateral and anodal stimulation of the affected primary motor cortex significantly improved upper limb function, as measured by the Jebsen-Taylor Test.

Sham stimulation and extra-cephalic tDCS did not produce significant effects, highlighting the importance of electrode placement in optimizing tDCS for stroke rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: electrode montage in stroke. Mahmoudi, H., Borhani Haghighi, A., Petramfar, P., et al.[2016]

In a study involving 44 stroke patients, those who received anodal transcranial direct current stimulation alongside constraint-induced movement therapy showed greater improvements in upper limb function compared to those who received sham stimulation.

Both treatment groups improved on the Wolf Motor Function Test, but the anodal stimulation group had significantly better outcomes, indicating that this combination therapy may enhance rehabilitation effectiveness for stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. Figlewski, K., Blicher, JU., Mortensen, J., et al.[2018]

The novel high-definition transcranial direct current stimulation (HD-tDCS) setup was found to be safe and well-tolerated, with fewer adverse effects compared to conventional tDCS, based on a study involving 60 healthy participants.

HD-tDCS significantly improved cognitive performance on a visual task, indicating its potential for more effective neural modulation, while also being compatible with simultaneous fMRI without causing significant heating or image quality issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. Gbadeyan, O., Steinhauser, M., McMahon, K., et al.[2022]

Transcranial direct current stimulation (tDCS) is a safe and well-tolerated technique, with no serious adverse effects reported in a study involving 131 healthy subjects across 277 sessions.

While sensory side effects like tingling and itching are common, they are generally mild; however, the higher occurrence and severity of these side effects during active stimulation compared to sham stimulation suggest that the current sham method may not be an effective control in some research contexts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differences in the experience of active and sham transcranial direct current stimulation. Kessler, SK., Turkeltaub, PE., Benson, JG., et al.[2021]

Transcranial direct current stimulation (tDCS) has been found to be safe for use in humans, with no severe complications reported in studies involving both adults and children when applied at intensities of 4 mA or less for up to 60 minutes.

Animal studies indicate that the electrical current used in tDCS is significantly lower than the threshold that could cause permanent changes to brain tissue, suggesting a strong safety profile for this neurorehabilitation method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. Ko, MH.[2023]

Microdermabrasion significantly reduced skin resistance by about 32%, allowing for higher doses of transcranial direct current stimulation (tDCS) without increasing skin sensations or device limitations.

The study found that while microdermabrasion increased perceived sensations slightly when not combined with sonication, overall, it enabled safer and more effective delivery of tDCS by lowering the voltage needed to achieve the same current.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. Chhatbar, PY., Liu, S., Ramakrishnan, V., et al.[2023]

Transcranial Direct Current Stimulation (tDCS) has been shown to be safe, with no reports of Serious Adverse Effects or irreversible injuries across over 33,200 sessions involving more than 1,000 subjects, including vulnerable populations.

Safety assessments indicate that the current densities used in conventional tDCS (≤4 milliamperes) are significantly lower than those that could potentially cause brain injury, suggesting that tDCS protocols are well within safe limits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. Bikson, M., Grossman, P., Thomas, C., et al.[2022]

Transcranial Direct Current Stimulation (tDCS) is generally considered safe, but there are concerns that it could lead to significant negative effects in healthy individuals.

The scientific community needs to be alerted about the potential risks of tDCS, emphasizing the importance of protecting healthy volunteers from possible harm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. Boccard-Binet, S., Sen, A.[2021]

In a study involving 22 chronic stroke patients, the combination of repetitive peripheral nerve sensory stimulation (RPSS) and transcranial direct current stimulation (tDCS) did not enhance the effects of functional electrical stimulation (FES) on wrist movement compared to using either intervention alone or a sham treatment.

While there were some improvements in grasp force and wrist extension in the nonparetic limb, the study found no significant benefits from the different stimulation combinations for the primary outcome of active wrist extension in the paretic limb.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined Brain and Peripheral Nerve Stimulation in Chronic Stroke Patients With Moderate to Severe Motor Impairment. Menezes, IS., Cohen, LG., Mello, EA., et al.[2022]

In a double-blind randomized controlled trial involving patients with upper limb motor impairment after intracerebral hemorrhage, combining transcranial direct current stimulation (tDCS) with home-based occupational therapy led to significant improvements in grip strength compared to occupational therapy alone.

While both groups showed improvement in activities of daily living, the anodal tDCS group demonstrated a trend towards greater improvement, suggesting that tDCS could be a beneficial addition to rehabilitation strategies, although further research is needed for long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined transcranial direct current stimulation and home-based occupational therapy for upper limb motor impairment following intracerebral hemorrhage: a double-blind randomized controlled trial. Mortensen, J., Figlewski, K., Andersen, H.[2016]

A 54-year-old woman with chronic moderate upper-extremity hemiparesis showed significant improvements in motor function after participating in 24 sessions of repetitive task-specific training (RTP) combined with transcranial direct current stimulation (tDCS) over 8 weeks.

The intervention led to marked increases in scores on the Fugl-Meyer Scale and the Motor Activity Log, indicating that tDCS combined with RTP can effectively reduce impairment and enhance upper-extremity use in chronic stroke patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functional Brain Stimulation in a Chronic Stroke Survivor With Moderate Impairment. Peters, HT., Pisegna, J., Faieta, J., et al.[2018]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effects of Bihemispheric Transcranial Direct Current Stimulation on Upper Extremity Function in Stroke Patients: A randomized Double-Blind Sham-Controlled Study. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Transcranial Direct Current Stimulation on Severely Affected Arm-Hand Motor Function in Patients After an Acute Ischemic Stroke: A Pilot Randomized Control Trial. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transcranial direct current stimulation: electrode montage in stroke. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial Direct Current Stimulation Potentiates Improvements in Functional Ability in Patients With Chronic Stroke Receiving Constraint-Induced Movement Therapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Safety, Tolerability, Blinding Efficacy and Behavioural Effects of a Novel MRI-Compatible, High-Definition tDCS Set-Up. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Differences in the experience of active and sham transcranial direct current stimulation. [2021]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Microdermabrasion facilitates direct current stimulation by lowering skin resistance. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Safety of transcranial direct current stimulation in healthy participants. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Combined Brain and Peripheral Nerve Stimulation in Chronic Stroke Patients With Moderate to Severe Motor Impairment. [2022]

12. England pubmed.ncbi.nlm.nih.gov

Combined transcranial direct current stimulation and home-based occupational therapy for upper limb motor impairment following intracerebral hemorrhage: a double-blind randomized controlled trial. [2016]

13. United States pubmed.ncbi.nlm.nih.gov

Functional Brain Stimulation in a Chronic Stroke Survivor With Moderate Impairment. [2018]